More than a dozen controversial drugs, including popular non-steroidal anti-inflammatory drug nimesulide, anti-depression drug deanxit, nasal decongestant phenylpropanolamine, antibiotic drug gatifloxacine, fertility drug letrozole, lipid lowering cholesterol control agent rosuvastatin, COX-2 inhibitors, analgen, anti-psychotic drug thioridazine, anti-dysentry drug furazoidone, etc will soon come under the scanner of the government as the DCGI office is all set to activate the national pharmacovigilance programme.
“All these highly controversial drugs, which are either banned or became controversial in several countries especially the developed nations for adverse health effects, will be put under the 'Focus Pharmacovigilance' programme under the national pharmacovigilance programme for which the ball has already been set rolling,” DCGI Dr Surinder Singh said. While most controversial drugs will be put under 'Focus Pharmacovigilance' programme, several other doubtful drugs will be put under the second category of the programme, Dr Singh added.
All India Institute for Medical Sciences (AIIMS), Delhi will be the nodal centre for the national pharmacovigilance programme for which the DCGI office (CDSCO) in Delhi will provide all the financial and logistical support. Head of the Pharmacology Department at AIIMS will be the ex-officio national in charge for the programme. Presently, Dr YK Gupta is the head of Pharmacology Department at AIIMS. All the four CDSCO zonal offices located at Ghaziabad, Kolkata, Mumbai and Chennai will function as the peripheral centres for the programme.
In the first phase by the end of January this year, the pilot programme will be launched in 40 of the 294 medical colleges in different parts of the country. All the four CDSCO zonal offices will soon shortlist at least 10 medical colleges in their respective zones for launching the programme. In the second phase, around 150 medical colleges will be brought under the programme, and if all goes as per the plan, all the 294 medical colleges in the country will be brought under the programme by the year 2012, Dr Singh said.
A roadmap for launching the programme was adopted at a workshop held at AIIMS on December 29 and 30. The meeting proposed to approach the Medical Council of India (MCI) to introduce pharmacovigilance in the curriculum of the medical students at the undergraduate level which will help to know how to run the pharmacovigilance programme and their role in it.